MAUDE Adverse Event Report: CARDINAL HEALTH DOBBHOFF 12FR 43IN W STYLET EN; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number 8884711253E

Device Problems Difficult to Remove (1528); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

The customer reported difficulty pulling the stylet once placement was confirmed.The tubing was flushed with water to lubricate it before the stylet was pulled, but it got kinked and required an uncomfortable amount of force to remove the stylet.No patient injury.

Manufacturer Narrative

The device history record was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the reported issue.Two photos were provided for analysis but the reported issue could not be confirmed.No physical samples were provided for further analysis.A gemba was carried out in the manufacturing process.Current process and controls were found to be followed correctly, including subassemblies, finished product assembly, packaging, and product inspections.No abnormal conditions were found that could trigger the reported condition.The current controls includes a 100% visual inspection by production personnel.In addition, a qc sampling inspection is performed to ensure that product is free from missing components, damaged components, inappropriate assembly and contamination.Based on the present information, an exact root cause cannot be determined.No action plan is deemed required at this time.The investigation will be reopened if a sample is received at a later date.This complaint will be used for tracking and trending purposes.

• Brand Name: DOBBHOFF 12FR 43IN W STYLET EN
• Type of Device: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 15738598
• MDR Text Key: 307509489
• Report Number: 9612030-2022-03451
• Device Sequence Number: 1
• Product Code: PIF
• UDI-Device Identifier: 10884521582927
• UDI-Public: 10884521582927
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8884711253E
• Device Catalogue Number: 8884711253E
• Device Lot Number: 2128511864
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/02/2022
• Date Device Manufactured: 10/18/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1